When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral load rises and the body's immune system is exposed to more HIV. This may lead to the body mounting a better immune response against the virus. The purpose of this study is to find out if taking interleukin-2 (also called IL-2 or aldesleukin) while stopping anti-HIV drugs for short periods of time can help patients control their HIV viral load.

Study hypothesis: Patients in this study will have lower virologic rebound and will maintain their CD4 cell counts for a longer time than other patients in comparative studies.

An Exploratory, Open-Label, Randomized Trial to Evaluate the Ability of Interleukin-2 (IL-2) to Enhance HIV-Specific Immunity and Influence the Time to Virologic Relapse Following Withdrawal of Potent Antiretroviral Therapy

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Mean of log10 HIV-1 RNA copies/ml obtained at Weeks 11 and 12 following the final interruption of potent antiretroviral therapy

Estimated Enrollment:

21

Study Completion Date:

May 2006

Detailed Description:

Structured treatment interruptions (STIs) may stimulate an anti-HIV immune response. Evidence suggests that IL-2, which increases CD4 counts, could also enhance specific immune responses to HIV. Enhanced immune responses could influence the magnitude of and the time to virologic rebound following treatment discontinuation. This study will compare the viral loads present after 12 weeks of an antiretroviral therapy (ART) interruption period between patients who have received different dosing regimens of IL-2 and have taken part in at least two STIs.

This study will last 40 to 104 weeks. IL-2 is provided as part of this study; potent ART is not provided. Patients in this study will receive potent ART with at least two scheduled potent ART interruptions. Patients will be randomly assigned to one of two treatment arms. Arm A patients will receive low-dose injections of IL-2 for 3 weeks, during the last 2 weeks of potent ART interruption periods and the first week of restarting potent ART. Arm B patients will receive high-dose injections of IL-2 during the first 5 days of restarting potent ART after the interruption period. The first two ART interruptions are 4 weeks in duration, followed by 12 weeks back on ART. Depending on the patient's viral load and CD4 count at Week 32, patients will either enter a third potent ART interruption for 12 to 48 weeks or will continue ART. No IL-2 will be given with the third scheduled potent ART interruption. Throughout the study, participants will have physical exams and laboratory tests, including measurements of viral load and CD4 count.

Eligibility

Ages Eligible for Study:

Child, Adult, Senior

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Note: ACTG A5132 closed to accrual on 11/01/04.

Inclusion Criteria:

HIV infected

CD4 cell count of 300 cells/mm3 or more within 30 days prior to study entry

HIV viral load of less than 50 copies/ml within 30 days prior to study entry

HIV viral load of 50 copies/ml or more within 60 days before study entry

Current use of experimental anti-HIV drugs other than FDA sanctioned investigational drugs

Abacavir as part of anti-HIV regimen within 8 weeks prior to study entry

Pregnant or breastfeeding

History of autoimmune disease, except for stable autoimmune thyroid disease

Heart problems or on certain medications for treatment of heart problems

Cancer requiring chemotherapy

Untreated thyroid disease

Disease of the central nervous system that has been active within 1 year prior to study entry

Uncontrolled diabetes

Allergies to the study medications

Other illnesses that would make it inappropriate for patients to participate in the study

Immunomodulatory therapy within 4 weeks prior to study entry

Hydroxyurea within 6 months prior to study entry

Drug or alcohol use that, in the opinion of the investigator, would interfere with the study

Psychiatric or mental impairment that would affect compliance

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038259